Interest of Skin Graft Pellets in the Management of Ulcers Algic
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Assessment of change of pain by Numeric Evaluation Scale
研究概览
简要总结
Leg ulcers (UDJ) is defined as a chronic skin wound, lasting for more than 4 to 6 weeks, between the knee and foot, and with no tendency to spontaneous healing.
In 2002, the prevalence of leg ulcers is estimated between 0.5% and 1% of the general population and 3% in subjects over 65 years.
The sex ratio is generally 3 females to 1 male. It is in most cases a complication of vascular disease, usually venous (70 to 90%), then blood (5-15%), mixed (5-10%) and microcirculatory.
In three quarter of cases, the UDJ is a chronic painful wound to the social repercussions (sleep disorders, eating, work stoppages) and major economic (individual and collective costs of absorptions).
The treatment of a chronic wound uses validated techniques for several years as the skin graft in tablets, associated with the etiological treatment.
The latest recommendations HAS implemented to date from 2006 and concerns the management of leg ulcers predominantly venous.
Few articles in the literature address the possibility of an analgesic effect of the transplant pellets in the treatment of chronic ulcers algic.
In 2008, a Swedish article, evaluated pain before and after skin grafting in carriers of leg ulcer patients and feet and showed that there was a reduction in pain post transplant.
We propose to evaluate the analgesic effect of the skin graft in pellet on a patient population having one or more Algic ulcers.
详细描述
Development of the study:
An information note and the non-opposition of the patient will be collected on the first day of hospitalization. The written and signed consent will be recorded in the patient record.
Clinical data will be collected during hospitalization of the patient, respecting his anonymity only initials and year of birth will be made in terms of data that distinguish patients.
The EQ-5D questionary will be distributed at the beginning of hospitalization and completed by each patient, and will evaluate the impact of painful ulcers in their daily lives.
Finally, a pain assessment questionary by NE (Numeric Evaluation) before and after the skin graft pellet, will be filled by a caregiver during an interview with each patient.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inpatient consecutively
- •over 18 years old, man, woman,
- •having one or more ulcers of venous, arterial or microcirculatory
- •for more than four to six weeks
- •answering yes to the question: is it painful ulcer?
- •consultant in vascular medicine department of St. Joseph hospital in February the month of April 2015
排除标准
- •Patients minors
- •Patients with dementia
结局指标
主要结局
Assessment of change of pain by Numeric Evaluation Scale
时间窗: Day -1, Day 1 and Day 7
A pain assessment questionnaire by Numeric Evaluation Scale NE (pain rating scale measuring pain intensity from 0 to 10) before and after the skin graft pellet, will be filled by a caregiver during an interview with each patient
次要结局
- Assessment of change of the impact of painful ulcers usin EQ-5D Questionary(Day -1, Day 1 and Day 7)